Evaluation of Ocular Surface in Hemodialysis Patients by Ocular Surface Analyzer

We clinically observed that some hemodialysis patients had corneal epithelial dryness, shedding, edema, and persistent epithelial nonunion after ocular surgery, which seriously affected the effect of surgery, and it is necessary to study the ocular surface characteristics of hemodialysis patients. In this study, we examined the ocular surface and analyzed and investigated the characteristics of the ocular surface in hemodialysis patients to provide a basis for ocular surface intervention or treatment in hemodialysis patients before ocular surgery in clinical practice.

Study Overview

• Status: Completed
• Conditions: Hemodialysis; Dry Eye; Ocular Surface Disease; OSDI
• Intervention / Treatment: Device: ocular surface analyzer

Detailed Description

This study is a clinical case-control study. A total of 36 hemodialysis patients and 36 normal subjects were randomly selected from the Nephrology Department of the First Affiliated Hospital of Jinan University .All the subjects in the hemodialysis group (n = 36, 72 eyes) and the normal group (n = 36, 72 eyes) were investigated with the OSDI scale, and then bilateral ocular surface examinations were performed with Keratograph5M eye surface comprehensive analyzer. Non-invasive tear meniscus height (NITMH), first tear film break-up time (FTBUT), average tear film break-up time (ATBUT), dry eye severity grade, tear film lipid layer analysis (distribution and color), tear film lipid layer thickness grade, meibomian gland opening blocking site, meibomian gland opening blocking analysis, meibomian gland opening secretion oil character score, eye redness index analysis (conjunctiva, ciliary shape), and meibomian gland absence area score were recorded.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • The First Affiliated Hospital of Jinan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A total of 36 hemodialysis patients and 36 normal subjects were randomly selected from the Nephrology Department of the First Affiliated Hospital of Jinan University .

Description

the hemodialysis group Inclusion Criteria:

• Older than 18
• Hemodialysis patient
• The subject understands the purpose of this clinical trial and agrees to sign an informed consent form.

the hemodialysis group Exclusion Criteria:

• Previous history of ocular trauma or surgery
• History of wearing contact lenses
• Can Not Stop the use of dry eye caused by drugs and other drugs may directly affect the stability of tear film tears
• Eyelid abnormalities (such as eyelid insufficiency, entropion and ECTROPION, tumor, severe trichiasis)
• There have been peritoneal dialysis, kidney transplant surgery patients.

the normal group Inclusion Criteria:

• Older than 18
• Healthy people do not have other systemic diseases, such as diabetes and hypertension
• The subject understands the purpose of this clinical trial and agrees to sign an informed consent form.

the normal group Exclusion Criteria:

• Previous history of ocular trauma or surgery
• History of wearing contact lenses
• Can Not Stop the use of dry eye caused by drugs and other drugs may directly affect the stability of tear film tears.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
the hemodialysis group; investigated with the OSDI scale, and then bilateral ocular surface examinations were performed with Keratograph5M eye surface comprehensive analyzer. Non-invasive tear meniscus height (NITMH), first tear film break-up time (FTBUT), average tear film break-up time (ATBUT), dry eye severity grade, tear film lipid layer analysis (distribution and color), tear film lipid layer thickness grade, meibomian gland opening blocking site, meibomian gland opening blocking analysis, meibomian gland opening secretion oil character score, eye redness index analysis (conjunctiva, ciliary shape), and meibomian gland absence area score were recorded.	Device: ocular surface analyzer; Using ocular surface analyzer for Inspection
the normal group; investigated with the OSDI scale, and then bilateral ocular surface examinations were performed with Keratograph5M eye surface comprehensive analyzer. Non-invasive tear meniscus height (NITMH), first tear film break-up time (FTBUT), average tear film break-up time (ATBUT), dry eye severity grade, tear film lipid layer analysis (distribution and color), tear film lipid layer thickness grade, meibomian gland opening blocking site, meibomian gland opening blocking analysis, meibomian gland opening secretion oil character score, eye redness index analysis (conjunctiva, ciliary shape), and meibomian gland absence area score were recorded.	Device: ocular surface analyzer; Using ocular surface analyzer for Inspection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-invasive tear meniscus height	Maximum and minimum of Non-invasive tear meniscus height in millimetre，higher scores mean a better outcome.	1year
first tear film break-up time	Maximum and minimum of first tear film break-up time in Seconds，higher scores mean a better outcome.	1year
average tear film break-up time	Maximum and minimum of average tear film break-up time in Seconds，higher scores mean a better outcome.	1year
dry eye severity grade	Maximum and minimum of dry eye severity grade，higher scores mean a worse outcome.	1year
tear film lipid layer analysis (distribution and color)	Maximum and minimum of tear film lipid layer analysis (distribution and color)，higher scores mean a better outcome.	1year
tear film lipid layer thickness grade	Maximum and minimum of tear film lipid layer thickness grade,higher scores mean a better outcome.	1year
meibomian gland opening blocking site	Maximum and minimum of meibomian gland opening blocking site，higher scores mean a worse outcome.	1year
meibomian gland opening blocking analysis	Maximum and minimum of meibomian gland opening blocking analysis，higher scores mean a worse outcome.	1year
meibomian gland opening secretion oil character score	Maximum and minimum of meibomian gland opening secretion oil character score，higher scores mean a worse outcome.	1year
eye redness index analysis (conjunctiva, ciliary shape)	Maximum and minimum of eye redness index analysis (conjunctiva, ciliary shape)，higher scores mean a worse outcome.	1year
meibomian gland absence area score	Maximum and minimum of meibomian gland absence area score，higher scores mean a worse outcome.	1year

Collaborators and Investigators

• Sponsor: XiaoYong Liu

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: June 26, 2021
• First Submitted That Met QC Criteria: June 26, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 17, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: 2021JN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No